Paul Stamets

Patent Trials and Appeals Board

Feb 9, 2022

2021002989 (P.T.A.B. Feb. 9, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 16/285,457 02/26/2019 Paul Edward Stamets 215261-9002-US04 3513 23409 7590 02/09/2022 MICHAEL BEST & FRIEDRICH LLP (Mke) 790 N WATER ST SUITE 2500 MILWAUKEE, WI 53202 EXAMINER HAYES, ROBERT CLINTON ART UNIT PAPER NUMBER 1649 NOTIFICATION DATE DELIVERY MODE 02/09/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): mkeipdocket@michaelbest.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte PAUL EDWARD STAMETS ____________ Appeal 2021-002989 Application 16/285,457 Technology Center 1600 ____________ Before DONALD E. ADAMS, ERIC B. GRIMES, and ULRIKE W. JENKS, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s decision to reject claims 1, 20, 21, 27-35, 41, and 42 (Appeal Br. 5).2 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as “Paul Edward Stamets . . . the founder and owner of Fugi Perfecti LLC, a Washington Limited Liability Company” (Appellant’s October 22, 2020, Supplemental Appeal Brief (Appeal Br.) 3). 2 Appellant’s claims 22-26 and 36-40 stand withdrawn from consideration (Appeal Br. 5). Appeal 2021-002989 Application 16/285,457 2 We have jurisdiction under 35 U.S.C. § 6(b).3 We AFFIRM. STATEMENT OF THE CASE Appellant’s disclosure “relates to neuroregenerative compositions based upon constituents isolated from or contained within mushroom fruitbodies or mycelia, or the corresponding synthetic molecules, combined with niacin” (Spec.4 1:9−11). Appellant’s claims 1, 20, and 21 are reproduced below: 1. A composition comprising: 0.1 mg to 10 mg of psilocybin, psilocin, baeocystin, norbaeocystin salts thereof, or combinations thereof; and one or more pharmaceutically acceptable excipients selected from buffering agents, antimicrobial preservatives, antioxidants, suspension agents, a tablet or capsule diluent, or a tablet disintegrant. (Appeal Br. 36.) 20. The composition of claim 1, wherein the composition further comprises 1 mg to 200 mg of erinacines, hericenones, or combinations thereof. (Id.) 21. The composition of claim 1, wherein the composition further comprises 1 mg to 200 mg of niacin. (Id.) 3 This Appeal is related to Appeal 2020-006595, Application 16/211,281 (’281 Application). The Application currently on Appeal is a divisional of the ’281 Application. An Opinion affirming the written description and statutory subject matter rejections was entered into the record of the ’281 Application on Nov. 25, 2020. 4 Appellant’s February 26, 2019, Specification. Appeal 2021-002989 Application 16/285,457 3 Grounds of rejection before this Panel for review: Claims 1, 20, 21, 27-35, 41, and 42 stand rejected under the written description provision of 35 U.S.C. § 112(a). Claims 1, 20, 21, 27-35, 41, and 42 stand rejected under 35 U.S.C. § 101. Written Description: ISSUE Does the preponderance of evidence on this record support Examiner's finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention? ANALYSIS Appellant’s claim 1 is representative and reproduced above. Examiner finds “that the formulations disclosed [on] pages 5-9 & 15 of [Appellant’s] [S]pecification fail to contemplate ‘baeocystin’ nor ‘norbaeocystin’ mg concentrations” (Ans.5 6). In addition, Examiner finds that “‘equivalent molar’ amounts . . . must include amounts of a solution, by definition, and therefore, cannot be equivalent to mg amounts” (id.). As Examiner explains, modifications to a chemical structure reasonably change their efficacy, and therefore, what amounts are effective in a functional composition. Here, the instant specification fails to describe a single derivative or analog thereof, or a single 5 Examiner’s February 3, 2021, Answer. Appeal 2021-002989 Application 16/285,457 4 specific substitution within any molecule, in context of a specific “mg” amount in a functional composition. (Id.) Thus, Examiner finds that Appellant’s Specification fails to provide written descriptive support “for the recitations of specific ‘mg’ amounts for ‘baeocystin or norbaeocystin,’” recited in Appellant’s claimed invention (id.). In response, Appellant contends that “[p]erhaps the term ‘equimolar’ is inaccurate with respect to mg quantities” (Appeal Br. 32). Examiner emphasizes that this “actually is the issue” on this record (see Ans. 14). We acknowledge Appellant’s contention that its Specification “expressly states that ‘equimolar amounts of analog’ or ‘amounts producing equivalent functional effects’ may be used” and “the phrase ‘amounts producing equivalent functional effects’ makes clear that a similar amount of the analog may be used as psilocybin or psilocin, as specified in [Appellant’s] claims” (Appeal Br. 32). As Examiner explains, however, “without reciting what ‘equivalent functional effect’ in the claims is to be assayed, one cannot reasonably conclude what exact amount results in an ‘equivalent functional effect’, especially when different amounts could be required for different functions” (Ans. 14). In this regard, Examiner reasons that “any specific functional characteristic of a compound is directly related to its actual structure, and therefore, reasonably different analogs possess different relative functions and/or efficacies” (id.; cf. Appeal Br. 33 (citing Spec. 5: 4-5) (Appellant contends that its Specification discloses “[t]he term ‘effective amount’ or ‘therapeutic amount’ refers to an amount sufficient to have neurogenerative activity”) (alteration original)). We agree with Examiner’s rationale. Appeal 2021-002989 Application 16/285,457 5 CONCLUSION The preponderance of evidence on this record supports Examiner’s finding that Appellant’s Specification fails to provide written descriptive support for the claimed invention. The rejection of claim 1 under the written description provision of 35 U.S.C. § 112, first paragraph is affirmed. Claims 20, 21, 27-35, 41, and 42 are not separately argued and fall with claim 1. Subject Matter Eligibility: ISSUE Does the preponderance of evidence of record support Examiner’s finding that Appellant’s claimed invention is directed to patent-ineligible subject matter? PRINCIPLES OF LAW A. Section 101 An invention is patent-eligible if it claims a “new and useful process, machine, manufacture, or composition of matter.” 35 U.S.C. § 101. However, the U.S. Supreme Court has long interpreted 35 U.S.C. § 101 to include implicit exceptions: “[l]aws of nature, natural phenomena, and abstract ideas” are not patentable. E.g., Alice Corp. v. CLS Bank Int’l, 573 U.S. 208, 216 (2014). In determining whether a claim falls within an excluded category, we are guided by the Court’s two-part framework, described in Mayo and Alice. Alice, 573 U.S. at 217-18 (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 75-77 (2012)). In accordance with that framework, we first determine what concept the claim is “directed to.” See Alice, 573 U.S. at 219 (“On their face, the claims before us are drawn to the concept of Appeal 2021-002989 Application 16/285,457 6 intermediated settlement, i.e., the use of a third party to mitigate settlement risk.”); see also Bilski v. Kappos, 561 U.S. 593, 611 (2010) (“Claims 1 and 4 in petitioners’ application explain the basic concept of hedging, or protecting against risk.”). Concepts determined to be abstract ideas, and thus patent ineligible, include certain methods of organizing human activity, such as fundamental economic practices (Alice, 573 U.S. at 219-20; Bilski, 561 U.S. at 611); mathematical formulas (Parker v. Flook, 437 U.S. 584, 594-95 (1978)); and mental processes (Gottschalk v. Benson, 409 U.S. 63, 67 (1972)). Concepts determined to be patent eligible include physical and chemical processes, such as “molding rubber products” (Diamond v. Diehr, 450 U.S. 175, 191 (1981)); “tanning, dyeing, making water-proof cloth, vulcanizing India rubber, smelting ores” (id. at 182 n.7 (quoting Corning v. Burden, 56 U.S. 252, 267-68 (1854))); and manufacturing flour (Benson, 409 U.S. at 69 (citing Cochrane v. Deener, 94 U.S. 780, 785 (1876))). In Diehr, the claim at issue recited a mathematical formula, but the Court held that “a claim drawn to subject matter otherwise statutory does not become nonstatutory simply because it uses a mathematical formula.” Diehr, 450 U.S. at 187; see also id. at 191 (“We view respondents’ claims as nothing more than a process for molding rubber products and not as an attempt to patent a mathematical formula.”). Having said that, the Court also indicated that a claim “seeking patent protection for that formula in the abstract . . . is not accorded the protection of our patent laws, and this principle cannot be circumvented by attempting to limit the use of the formula to a particular technological environment.” Id. (citation omitted) (citing Benson and Flook); see, e.g., id. at 187 (“It is now commonplace that Appeal 2021-002989 Application 16/285,457 7 an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.”). If the claim is “directed to” an abstract idea, we turn to the second step of the Alice and Mayo framework, where “we must examine the elements of the claim to determine whether it contains an ‘inventive concept’ sufficient to ‘transform’ the claimed abstract idea into a patent- eligible application.” Alice, 573 U.S. at 221 (internal quotation marks omitted). “A claim that recites an abstract idea must include ‘additional features’ to ensure ‘that the [claim] is more than a drafting effort designed to monopolize the [abstract idea].’” Id. (alterations in original) (quoting Mayo, 566 U.S. at 77). “[M]erely requir[ing] generic computer implementation[] fail[s] to transform that abstract idea into a patent-eligible invention.” Id. B. USPTO Section 101 Guidance In January 2019, the U.S. Patent and Trademark Office (USPTO) published revised guidance on the application of § 101. 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019) (“Guidance”).6 “All USPTO personnel are, as a matter of internal agency management, expected to follow the guidance.” Id. at 51; see also October 2019 Update at 1. 6 In response to received public comments, the Office issued further guidance on October 17, 2019, clarifying the 2019 Revised Guidance. USPTO, October 2019 Update: Subject Matter Eligibility (the “October 2019 Update”) (available at https://www.uspto.gov/sites/default/files/ documents/peg_oct_2019_update.pdf). Appeal 2021-002989 Application 16/285,457 8 Under the Guidance and the October 2019 Update, we first look to whether the claim recites: (1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes) (“Step 2A, Prong One”); and (2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h) (9th ed. Rev. 08.2017, Jan. 2018)) (“Step 2A, Prong Two”).7 Guidance, 84 Fed. Reg. at 52-55. Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look, under Step 2B, to whether the claim: (3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or (4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Guidance, 84 Fed. Reg. at 52-56. ANALYSIS (Step 1) Appellant claims compositions of matter, a statutory category of invention (see Appeal Br. 18 (“Each of claims 1, 20, [and] 21 . . . is drawn to 7 This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See Guidance - Section III(A)(2), 84 Fed. Reg. at 54-55. Appeal 2021-002989 Application 16/285,457 9 a composition of matter, which is a category of statutory eligible subject matter”)). Therefore, we proceed to the next steps of the analysis. (Step 2A, Prong 1) The composition of Appellant’s claim 1, reproduced above, comprises: (a) 0.1 mg to 10 mg of psilocybin, psilocin, baeocystin, norbaeocystin salts thereof, or combinations thereof and (b) one or more pharmaceutically acceptable excipients selected from buffering agents, antimicrobial preservatives, antioxidants, suspension agents, a tablet or capsule diluent, or a tablet disintegrant. The composition of Appellant’s claim 20, reproduced above, depends from and further limits Appellant’s claim 1 to further comprise 1 mg to 200 mg of erinacines, hericenones, or combinations thereof. The composition of Appellant’s claim 21, reproduced above, depends from and further limits Appellant’s claim 1 to further comprise 1 mg to 200 mg of niacin. There is no dispute on this record that (a) psilocybin, psilocin, baeocystin, norbaeocystin salts thereof, or combinations thereof; (b) erinacines, hericenones, or combinations thereof; and (c) niacin are natural products (see Appeal Br. 7 (Appellant contends that “[e]ach of these individual compounds are undoubtably natural products”); Ans. 4 (citing Spec. ¶ 2, 16) (Examiner finds that “[a]ll of the products of the instant claims are products of nature”)). Examiner further finds that water is a naturally-occurring pharmaceutically acceptable diluent or suspension agent (Ans. 4; see also id. at 12 (Examiner finds that water is a naturally occurring diluent/suspension agent/tablet disintegrant” and “fungi and plants necessarily contain water in Appeal 2021-002989 Application 16/285,457 10 nature.”)). Therefore, we are not persuaded by Appellant’s contention that “[w]ater is not a tablet or capsule diluent” within the scope of its claim or Specification (see Appeal Br. 27 (citing Appellant’s claim 1 and Spec. 10:19-22)). In addition, we do not find that the examples of tablet or capsule diluents provided in Appellant’s Specification is a definition of tablet or capsule diluents. To the contrary, the representative tablet or capsule diluents listed in Appellant’s Specification are simply examples of the types of agents that may serve that purpose. Further, although “it is true that claims are to be interpreted in light of the specification and with a view to ascertaining the invention, it does not follow that limitations from the specification may be read into the claims.” Sjolund v. Musland, 847 F.2d 1573, 1581 (Fed. Cir. 1988) (emphasis omitted). In sum, Appellant’s claimed invention recites mixtures of nature- based products. Because Appellant’s claimed invention recites nature-based product limitations, the markedly different characteristics analysis is used to determine if the nature-based product limitation is a product of nature exception (see October 2019 Update 1). Applying the markedly different characteristics analysis we find that there is no indication on this record that mixing the nature-based products according to Appellant’s claimed invention results in a transformation of the products or that the claimed mixtures have properties not possessed by the products in nature. See Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 591 (2013) (explaining that the bacterial mixture of Funk Brothers8 “was not patent eligible because the patent holder did not alter the 8 See Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948). Appeal 2021-002989 Application 16/285,457 11 bacteria in any way.”); see also, In re Bhagat, 726 F. App’x 772, 779 (Fed. Cir. 2018) (non-precedential) (“Applicant has not shown that the claimed mixtures are a ‘transformation’ of the natural products, or that the claimed mixtures have properties not possessed by these products in nature.”). Appellant broadly contends that “[t]he claimed compositions are not intended to be hallucinogenic, but rather for improving neurological function” (Appeal Br. 26). More specifically, Appellant contends that its claim 1 is “drawn to an article of manufacture (a pharmaceutical composition) and not the natural products themselves,” wherein, “[t]he isolation of the compounds, dispensing them in particular mg quantities, and the combination with excipients transforms these natural products into a non-natural ‘manufacture’ or ‘composition of matter’ that does not exist in the natural world” (id. at 19). Appellant contends that its claim 20 is “not directed to the individual natural products, but a manufactured composition that contains a combination of natural products. This is a practical application that has markedly different characteristics from the individual natural product components” (id. at 20). With respect to its claim 21, Appellant contends that although “psilocybin, psilocin, baeocystin, norbaeocystin, and niacin may coexist in Psilocybe mushrooms, the specific mg ranges of isolated compounds and the specified pharmaceutical excipients do not exist naturally” (id.). Appellant failed, however, to establish that the neurogenic effects of the nature-based products of its claimed mixture have markedly different neurogenic effects than the individual products themselves. See, e.g., Myriad Genetics, Inc., 569 U.S. at 591 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way.”). Appeal 2021-002989 Application 16/285,457 12 Thus, we are not persuaded by Appellant’s contention that its claimed composition is patent eligible simply because it is the result of a mixture of different nature-based products (see Appeal Br. 21 (Appellant contends “In the case here, specific natural products are isolated from their natural fungal organisms and formulated at specific dosages (and/or combined to form new combinations) with pharmaceutical excipients that have a different utility as a nutraceutical or nootropic therapeutic. Thus, Appellant’s claims are distinguishable from Funk Brothers.”); id. at 25 (Appellant contends that “the claimed [combination] of a tryptamine compound (e.g., psilocybin, psilocin, baeocystin, and norbaeocystin) with a pharmaceutical excipient, erinacine or hericenone, or niacin with specific mg dosages creates a new composition that is not found in nature. This is a transformation.”); id. at 26 (Appellant contends “[t]here is ample evidence in the words of the claims themselves and the record supporting the claimed compositions are not directed to natural products”)). For the foregoing reasons, we are not persuaded that Appellant’s claimed mixtures are markedly different from the nature-based products and, thus, we find that Appellant’s claims recite a judicial exception, i.e., a product of nature. (Step 2A, Prong 2) Having determined that Appellant’s claims recite a judicial exception, the Guidance requires an evaluation as to whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. See Guidance, 84 Fed. Reg. at 54-55. Appellant’s claims do not recite additional elements that are beyond the judicial exception (see Ans. 4 (Examiner finds that Appellant’s claims Appeal 2021-002989 Application 16/285,457 13 compositions do not include additional elements that are sufficient to amount to significantly more than the judicial exception (i.e., a natural phenomenon/natural product))). Thus, Appellant’s claimed invention fails to integrate the recited judicial exception into a practical application of the exception (see id. at 8 (Examiner finds “no additional elements recited in the claims that integrate the judicial exception . . . into a practical application; nor do the claims ‘recite additional elements that amount to significantly more than the judicial exception’,” Examiner “[i]nstead [finds that Appellant’s] claims merely recite a mixture of individual naturally-occurring components, and nothing else.”)). For the foregoing reasons, we are not persuaded by Appellant’s contention that “[p]silocybin and psilocin and erinacine and hericenone are not produced together by any known natural organism” and, thus, “[t]he combination of these two distinct sets of natural products is not a product of nature, but the practical integration of multiple natural products” (Appeal Br. 20). See, e.g., Myriad Genetics, Inc., 569 U.S. at 591 (explaining that the bacterial mixture of Funk Brothers “was not patent eligible because the patent holder did not alter the bacteria in any way.”). We are not persuaded by Appellant’s contention that “[t]he isolation of the compounds, dispensing them in particular mg quantities, and the combination with excipients transforms these natural products into a non- natural ‘manufacture’ or ‘composition of matter’ that does not exist in the natural world” (Appeal Br. 19; see also id. at 7 (Appellant contends that “[t]he isolated compounds, specific quantities, and the addition of pharmaceutical excipients transform the psilocybin natural product (among the other specified compounds) into a non-natural pharmaceutical Appeal 2021-002989 Application 16/285,457 14 ‘manufacture.’”); id. at 22-23 (Appellant contends that its claims “are patent eligible as compositions of matter containing specific quantities of isolated natural products and pharmaceutical excipients”); id. at 24 (Appellant contends that the combination of niacin “with the tryptamine compounds; the specified mg quantities create a composition that does not exist in any natural organism”)). As Example 309 explains, although “not discussed in the opinion, it is noted that several of the claims held ineligible in Funk Brothers recited specific amounts of the bacterial species in the mixture, e.g., claims 6, 7 and 13” (see Example 30 at 20, citing Funk Brothers, 333 U.S. at 128 n. l.). Thus, Appellant’s recitation of a mixture of specific amounts of nature-based products does not support a finding of subject matter eligibility on this record. (Step 2B) Having determined that Appellant’s claims: (1) recite a judicial exception and (2) do not integrate that exception into a practical application, the Guidance requires that we evaluate whether Appellant’s claims: (a) add a specific limitation beyond the judicial exception that is not “well- understood, routine, conventional” in the field or (b) simply appends well- understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Guidance, 84 Fed. Reg. at 52−56. 9 Example 30 - Dietary Sweeteners, Subject Matter Eligibility Examples: Life Sciences, 16-23, available at https://www.uspto.gov/sites/default/files/documents/101_examples_1to36.p df. Appeal 2021-002989 Application 16/285,457 15 As discussed above, Appellant’s claims do not recite additional elements that are beyond the judicial exception (see Ans. 4, 8) For the reasons set forth above, we are not persuaded by Appellant’s contentions under Step 2B, which are the same contentions set forth above, with respect to Step 2A, Prong 2 (see Appeal Br. 21 (“[T]he . . . aspects discussed above under Prong Two are directly applicable in Step 2B”)). For the reasons set forth above, we are not persuaded by Appellant’s contention that its claimed invention is patent eligible in view of Funk Brothers (see Appeal Br. 21). We are not persuaded by Appellant’s contention that its claimed invention is patent eligible in view of Diamond v. Chakrabarty, 447 U.S. 303 (1980) (see Appeal Br. 22). As Appellant explains, “Chakrabarty transformed plasmids into Pseudomonas bacteria, thus creating both a structural and functional change to the bacteria” (id. at 20). As discussed above, on this record, Appellant failed to establish that its claimed mixture of nature-based products have a different structure or function than those possessed by the products in nature. We are not persuaded by Appellant’s contention that its claimed invention is patent eligible in view of Natural Alternatives International, Inc. v. Creative Compounds, LLC, 918 F.3d 1338 (Fed. Cir. 2019); United Cannabis Corp. v. Pure Hemp Collective Inc., Civil Action No. 18-cv-1922- WJM-NYW, 2019 WL 1651846 (D. Colo. Apr. 17, 2019); and Ex parte McCausland, 2016-004128, 2017 WL 4180263 (PTAB Aug. 31, 2017) (see Appeal Br. 21-23). As Appellant explains, “[e]ach of Natural Alternatives, United Cannabis, and Ex parte McCausland involved the use of natural Appeal 2021-002989 Application 16/285,457 16 product(s) in specific formulations that had different structures (e.g., combinations or formulations), functions, and utilities than the original natural compounds” (id. at 22). As discussed above, on this record, Appellant failed to establish that its claimed mixture of nature-based products have a different structure, function, or utility than those possessed by the products in nature. Appellant also contends that its claimed invention is patent eligible in view of Example 1010 (see Appeal Br. 22). According to Appellant in Example 10, “two species of bacteria that do not naturally coexist were combined in milk, forming a patent eligible composition” (id.; see id. at 20 (Appellant contends that “[t]he combination of multiple natural products, which do not naturally coexist[], is both a transformation and a practical application of the judicial exception” and although “psilocybin, psilocin, baeocystin, norbaeocystin, and niacin may coexist in Psilocybe mushrooms, the specific mg ranges of isolated compounds and the specified pharmaceutical excipients do not exist naturally”)). We are not persuaded. As Example 10 explains, As described in the specification, when S. thermophilus and L. alexandrinus are mixed, the two bacterial species have different characteristics than either species does on its own, e.g., they act together to ferment milk into a lower fat yogurt than either bacteria can produce when individually mixed with the milk. Thus, the mixture of the bacteria and milk has different functional characteristics (lower fat content) than the naturally occurring bacteria (or milk) by itself. These differences rise to 10 Example 10 - Food, Subject Matter Eligibility Examples: Nature-Based Products, 16−17, available at https://www.uspto.gov/sites/default/files/documents/101_examples_1to36.p df.). Appeal 2021-002989 Application 16/285,457 17 the level of a marked difference, and accordingly the claimed starter culture is not a “product of nature” exception. Thus, the claim is not directed to an exception (Step 2A: NO), and qualifies as eligible subject matter. (Example 10 at 17.) As discussed above, on this record, Appellant failed to establish that its claimed mixture of nature-based products have different characteristics than those possessed by the products in nature. CONCLUSION The preponderance of evidence of record supports Examiner’s finding that Appellant’s claimed invention is directed to patent-ineligible subject matter. The rejection of claims 1, 20, and 21 under 35 U.S.C. § 101 is affirmed. Claims 27, 30, 33, 41, and 42 are not separately argued and fall with claim 1. Claims 28, 31, and 34 are not separately argued and fall with claim 20. Claims 29, 32, and 35 are not separately argued and fall with claim 21. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 1, 20, 21, 27-35, 41, 42 101 Eligibility 1, 20, 21, 27-35, 41, 42 1, 20, 21, 27-35, 41, 42 112(a) Written Description 1, 20, 21, 27-35, 41, 42 Overall Outcome 1, 20, 21, 27-35, 41, 42 Appeal 2021-002989 Application 16/285,457 18 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv) (2019). AFFIRMED